Atlas FDA

YSIO

FDA 510(k) clearance K081722 · decided 2008-08-22

Clearance details

K-number
K081722
Device name
YSIO
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
2008-06-18
Decision date
2008-08-22
Days to decision
65 days
Clearance type
Traditional
Product code
KPR
Device class
2
Regulation number
892.1680
Medical specialty
Radiology
Advisory committee
Radiology
Location
Malvern, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system. recall (Z-1501-2020)Siemens Medical Solutions USA, Inc2020-03-03
The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic recall (Z-2680-2014)Siemens Medical Solutions USA, Inc2014-09-23
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to b recall (Z-2292-2014)Siemens Medical Solutions USA, Inc2014-09-10
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software version recall (Z-1845-2014)Siemens Medical Solutions USA, Inc2014-06-21
Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic sys recall (Z-1717-2014)Siemens Medical Solutions USA, Inc2014-06-04
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia syste recall (Z-0374-2014)Siemens Medical Solutions USA, Inc2013-11-26
Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software version recall (Z-0016-2014)Siemens Medical Solutions USA, Inc2013-11-01
Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia Solid state x-ray i recall (Z-1159-2012)Siemens Medical Solutions USA, Inc2012-03-05
Siemens YSIO - solid state x-ray imager Solid state x-ray imager (flat panel/digital image recall (Z-2787-2011)Siemens Medical Solutions USA, Inc2011-07-11

PMA approvals by this applicant

RecordFirmDate
MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008)Siemens Medical Solutions USA, Inc.2024-09-23
MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007)Siemens Medical Solutions USA, Inc.2020-08-21
MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006)Siemens Medical Solutions USA, Inc.2019-12-10
Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005)Siemens Medical Solutions USA, Inc.2017-09-29
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003)Siemens Medical Solutions USA, Inc.2017-03-23
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001)Siemens Medical Solutions USA, Inc.2016-05-12
MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002)Siemens Medical Solutions USA, Inc.2016-01-13
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011)Siemens Medical Solutions USA, Inc.2015-04-21